At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3b, Open Label, Controlled, Multi-Center, Extension Study to Assess the Persistence of Bactericidal Activity at 4 to 7.5 Years After Two Dose Primary Series of GlaxoSmithKline Biologicals Meningococcal B Recombinant Vaccine and the Response to a Third Dose in Adolescents and Young Adult Subjects Who Previously Participated in Parent Studies V72_41 (NCT01423084) and V72P10 (NCT00661713), Compared to Naïve Healthy Controls
In Brief
A Phase 3 clinical trial evaluating rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine) for Infections, Meningococcal. Completed, enrolled 531 participants across 12 sites in 3 countries.
Detailed Summary
The purpose/aim of this study is to assess 1) the long-term persistence (4 to 7.5 years after the last dose) of bactericidal activity following primary vaccination with rMenB+OMV NZ in adolescents \[who previously participated in parent studies V72\_41 (NCT0142384) and V72P10 (NCT00661713)\] and 2) the kinetics of immune response following booster vaccination with rMenB+OMV NZ
Study Details
Timeline
Interventions
One dose of the vaccine administered intramuscularly in the deltoid area of the non-dominant arm.